Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

To support our clincal operations team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Clinical Study Administrator (gn)

Your responsibilities

In this posiition you will carry full responsibility in supporting the clinical study team in all aspects of the clinical study management and coordination. This will include the following tasks:

Support and/or lead assigned activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
Coordinate activities as it relates to development of clinical documents and other operational documents as appropriate as well as any updates/amendments to those documents
Preparation, distribution and filing of meeting minutes
Ensure timely entry and/or update appropriate information into tracking and communication tools, monitor study progress and proactively identify issues for resolution with the Clinical Study Manager
Support and management of vendor selection process
Support in IMP and study material supplies by liaising with service providers as appropriate
Coordinate all activities and documentation related to patient insurances, site/investigator contracting and payment administration
Organization of translations
Generation and maintenance of templates and documents
Support of formatting and finalizing documents
Project specific filing of documentation
Maintenance and Archiving of TMF
Adherence to internal quality standards and workflow

Your qualifications

Technical training (MTA / BTA / CTA / comparable) or university degree in life sciences
At least 2 years of relevant work experience
Well-organized team player
Problem-solving skills
Attention to detail
Good knowledge in MS Office
Fluent in English, German knowledge preferable

We offer

Flexible working time
Hybrid work
30 days paid vacation
Formycon pension
Group accident insurance
Formycon card
Continuing education offers
Team spirit, great working atmosphere and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application in English language through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

For any questions, please feel free to send us an email at email.

Apply now

Full-Time , Permanent

Specialist

Updated at 11/05/2024

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